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CTRI Number  CTRI/2021/04/032503 [Registered on: 01/04/2021] Trial Registered Prospectively
Last Modified On: 08/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   AYURVEDIC MANAGEMENT OF GOUTY ARTHRITIS - A CLINICAL STUDY  
Scientific Title of Study   A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VASADI KWATHA IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHILPA SHREE C 
Designation  SECOND YEAR PG SCHOLAR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  ROOM NUMBER 304, DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 21st KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE

Bangalore Rural
KARNATAKA
560082
India 
Phone  9663684380  
Fax    
Email  shilpa23197@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr NEELAKANTA J SAJJANAR 
Designation  ASSOCIATE PROFFESSOR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH  
Address  ROOM NUMBER 304, DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 21st KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE

Bangalore Rural
KARNATAKA
560082
India 
Phone  9844812331  
Fax    
Email  neelkant.ayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SHILPA SHREE C 
Designation  SECOND YEAR PG SCHOLAR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  ROOM NUMBER 304, DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 21st KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE

Bangalore Rural
KARNATAKA
560082
India 
Phone  9663684380  
Fax    
Email  shilpa23197@gmail.com  
 
Source of Monetary or Material Support  
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 
 
Primary Sponsor  
Name  Dr SHILPA SHREE C 
Address  PG SCHOLAR ROOM NUMBER 304, DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 21st KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SHILPA SHREE C  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL  ROOM NUMBER 05, DEPARTMENT OF KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21ST KM, KANAKAPURA ROAD, UDAYAPURA POST, BANGALORE,KARNATAKA.
Bangalore
KARNATAKA 		 9663684380

shilpa23197@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AMRITADI GUGGULU   AMRITADI GUGGULU IS A POLYHERBAL FORMULATION CONTAINING 12 INGREDIENTS.THEY ARE GUDUCHI, GUGGULU, HARITAKI, VIBHITAKI,AMALAKI,DANTI, SHUNTI, MARICHA, PIPPALI, VIDANGA, TRIVRUTH AND TWAK. DOSAGE:- 2 TABLETS TWICE DAILY AFTER FOOD WITH WARM WATER(Q.S)TWICE DAILY FOR 1 MONTH. 
Intervention  VASADI KWATHA   VASADI KWATHA IS A POLYHERBAL FORMULATION CONTAINING 4 INGREDIENTS: THEY ARE VASA, GUDUCHI, ARAGWADHA AND ERANDATAILA. DOSAGE- 50ML OF KWATHA WITH 5 ML OF ERANDA TAILA TWICE DAILY 1 HOUR BEFORE FOOD FOR 1 MONTH. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  SUBJECTS FULFILLING CRITERIAS OF AMERICAN COLLEGE OF RHEUMATOLOGY 1977 AND SUBJECTS WITH INCREASED LEVEL OF SERUM URIC ACID OF 7mg/dl to 10mg/dl IN MALE AND 6mg/dl to 10mg/dl IN FEMALE 
 
ExclusionCriteria 
Details  1. SUBJECTS DIAGNOSED WITH OTHER INFLAMMATORY AND DEGENERATIVE JOINT DISEASE
2. SUBJECTS WITH HISTORY OF TRAUMA, FRACTURE JOINT, SURGICAL OR DIAGNOSTIC INTERVENTION WITH REFERENCE TO THE AFFECTED JOINT(S) IN PAST 1 YEAR.
3. PREGNANT AND LACTATING WOMEN
4. SUBJECTS WITH ANY UNCONTROLLED SYSTEMIC ILLNESS INCLUDING DIABETES MELLITUS, HYPERTENSION.
5. SUBJECTS WITH VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS PRESENTING WITH COMPLICATION INCLUDING JOINT DEFORMITIES.
6. ANY OTHER CONDITION INTERFERING THE COURSE OF TREATMENT. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
REDUCTION IN THE LEVELS OF SERUM URIC ACID  30TH DAY, 45TH DAY 
 
Secondary Outcome  
Outcome  TimePoints 
REDUCTION IN THE CLASSICAL SIGNS AND SYMPTOMS OF VATARAKTA  REDUCTION IN THE SIGNS AND SYMPTOMS OF VATARAKTA ON 15th day, 30th DAY and 45th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/04/2021 
Date of Study Completion (India) 17/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 THIS STUDY WAS PUT FORWARD TO EVALUATE THE EFFICACY OF VASADI KWATHA IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS IN COMPARISION WITH AMRITADI GUGGULU.

HYPOTHESIS:
1. NULL HYPOTHESIS
    H0 :-THE EFFICACY OF VASADI KWATHA IS EQUIVALENT TO AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
2. ALTERNATE HYPOTHESIS
    H1:-THE EFFICACY OF VASADI KWATHA IS GREATER THAN AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.
    H2:- THE EFFICACY OF VASADI KWATHA IS LESSER THAN AMRITADI GUGGULU IN THE MANAGEMENT OF VATARAKTA WITH SPECIAL REFERENCE TO GOUTY ARTHRITIS.


The study was completed with 30 subjects randomly allocated into 2 groups comprising15 subjects each. Subjects in Group A were treated with Vasadi Kwatha and Subjects in Group B were treated with Amritadi Guggulu for an intervention period of 30 days and follow up was for 15 days. Assessment was done on basis of both objective and subjective parameters on 0th day, 15th day, 30th day and 45th day. 

On comparing the results between the groups, statistically non-significant results were obtained in all the parameters suggesting that, both Vasadi Kwatha and Amritadi Guggulu had equal effect in the management of Vatarakta. Thus,  Null hypothesis is accepted, i.e, The efficacy of Vasadi kwatha is equivalent to Amritadi Guggulu in the management of Vatarakta with special reference to Gouty Arthritis.
 
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